Brentuximab Vedotin in Treating Patients With Advanced Systemic Mastocytosis or Mast Cell Leukemia
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|ClinicalTrials.gov Identifier: NCT01807598|
Recruitment Status : Completed
First Posted : March 8, 2013
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aggressive Systemic Mastocytosis Mast Cell Leukemia Systemic Mastocytosis||Drug: brentuximab vedotin||Phase 2|
I. To evaluate the response rate to SGN-35 (brentuximab vedotin) in patients with tumor necrosis factor receptor superfamily, member 8 (CD30+) advanced systemic mastocytosis (SM) (ASM or mast cell leukemia [MCL] with or without an associated hematological clonal non-mast cell lineage disease [AHNMD]).
I. To evaluate the tolerability and safety profile of SGN-35 in patients with SM.
II. To evaluate expression of CD30 on neoplastic mast cells before and during therapy with SGN-35.
III. To evaluate changes in mastocytosis related symptom scores and quality of life (QOL) using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPNSAF).
IV. To evaluate the duration of response (DoR) and time to response (TTR). V. To evaluate progression-free survival (PFS).
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 weeks for 1 year and then every 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Brentuximab Vedotin (SGN-35) in CD30-Positive Systemic Mastocytosis With or Without an Associated Hematological Clonal Non-Mast Cell Lineage Disease (AHNMD)|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Brentuximab vedotin
Subjects receive a 30-minute IV infusion of brentuximab vedotin once every 21 days for 8 courses, in the absence of disease progression or unacceptable toxicity.
Drug: brentuximab vedotin
Brentuximab vedotin is an antibody with a covalently attached toxin. The antibody portion targets the protein CD30 on the surface of cells, and the toxin acts against those cells.
- Overall response rate per consensus international response criteria (rate of complete or partial remissions or clinical improvement) [ Time Frame: Up to 1 year ]Will be estimated and its 95% confidence interval will be provided.
- Immunohistochemical expression of CD30 on neoplastic mast cells in core biopsy samples by flow cytometry [ Time Frame: Up to 1 year ]The expression of CD30+ neoplastic mast cells in core biopsy samples compared between pre and post brentuximab vedotin treatment.
- Total symptom score using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) [ Time Frame: Up to 1 year ]Total symptom score will be calculated using a modified Myeloproliferative Neoplasm Symptom Assessment Form by recording mean and median scores compared to pre-treatment score.
- Duration of response [ Time Frame: Time from first onset of confirmed response to the date of first documented and confirmed progression or death, assessed up to 1 year ]The Kaplan-Meier product-limit method will be used to summarize.
- Time to response [ Time Frame: Time from start of treatment until the date of onset of a confirmed response, assessed up to 1 year ]The Kaplan-Meier product-limit method will be used to summarize.
- Progression-free survival (PFS) [ Time Frame: Time from start of treatment to the date of the first documented and confirmed progression or death or institution of new therapy, assessed up to 1 year ]The Kaplan-Meier product-limit method will be used to summarize.
- Type of adverse events measured by National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.03 [ Time Frame: Up to 1 year ]Toxicity to be assessed as the type and relatedness of adverse events to brentuximab vedotin.
- Quality of life (QOL) score using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) [ Time Frame: Up to 1 year ]Quality of life score will be calculated using a modified Myeloproliferative Neoplasm Symptom Assessment Form and will be compared to pre-treatment score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807598
|United States, California|
|Stanford University, School of Medicine|
|Stanford, California, United States, 94305|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jason Gotlib||Stanford University Hospitals and Clinics|